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18:24 EDT Arthur J. Gallagher acquires The Protectors Insurance Group - Arthur J. Gallagher announced the acquisition of Liverpool, New South Wales-based The Protectors Insurance Brokers and Regent Insurance Brokers Pty, collectively referred to as The Protectors Group. Terms of the transaction were not disclosed.

15:15 EDT Aduro Biotech, Novartis present results from ongoing Phase 1b study - Aduro Biotech (ADRO) announced the presentation of data from an ongoing Phase 1b clinical trial in collaboration with Novartis (NVS). Aduro's ADU-S100, a novel STING pathway activator, is being evaluated in combination with Novartis' spartalizumab, an investigational anti-PD-1 monoclonal antibody, in patients with advanced solid tumors or lymphomas. The Phase 1b multi-center, open-label, dose-escalation clinical trial enrolled patients with advanced, metastatic treatment-relapsed/refractory solid tumors or lymphomas and evaluated two treatment schedules. All patients received a fixed dose of 400 mg of intravenous spartalizumab on day 1 and either an intratumoral injection of ADU-S100 on days 1, 8 and 15 in a 28-day cycle or an IT injection of ADU-S100 on day 1 of every 28-day cycle. Data presented were based on findings from 83 enrolled patients, with 53 patients in the weekly group and 30 patients in the monthly group. No dose-limiting toxicities were reported during the first cycle in any of the 50 - 1,600 microg dose cohorts. The adverse events of the combination of ADU-S100 and spartalizumab reported were no more frequent or severe than those reported in either single agent trial. Treatment was discontinued in two patients due to adverse events. Five patients enrolled in the weekly group achieved confirmed responses - one CR and two PRs in anti-PD-1-naive TNBC, as well as two PRs in previously immunotherapy-treated melanoma. Eight of the 11 enrolled TNBC patients were evaluable for efficacy. Of the eight evaluable TNBC patients, the three patients with a CR/PR are continuing to receive treatment. Of the three unevaluable TNBC patients, one patient discontinued the study early due to toxicity (pneumonitis) and the two remaining patients are too early for assessment.

15:10 EDT Amgen announced data from Phase 1 studies on bispecific T cell engager molecules - Amgen announced new data from Phase 1 studies evaluating investigational bispecific T cell engager molecules were presented at the 55th Annual Meeting of the American Society of Clinical Oncology in Chicago. Data presented included updated investigational AMG 420 safety and efficacy results in patients with relapsed and/or refractory multiple myeloma, as well as initial results from the investigational AMG 212 first-in-human trial in patients with metastatic castration-resistant prostate cancer. BiTE technology is a targeted immuno-oncology platform that is designed to engage patients' own T cells to a tumor-specific antigen, activating the cytotoxic potential of T cells. Updated results from a Phase 1, first-in-human dose-escalation trial of investigational AMG 420, a B-cell maturation antigen (BCMA)-targeting BiTE molecule, in patients with R/R MM were shared during an oral presentation at the ASCO Annual Meeting. The objectives of the study included assessment of the safety, tolerability and anti-tumor activity of AMG 420 per International Myeloma Working Group 2006 Uniform Response Criteria for Multiple Myeloma. In the study, 42 patients with R/R MM who had progression after at least two prior lines of treatment received AMG 420 at varying doses. Of the doses tested in this study, 400 microg/d was the maximum tolerated dose. As of the latest readout, AMG 420 induced clinical responses in 13 of 42 patients across the dosing cohorts. Of the six patients that achieved a minimal residual disease-negative complete response, five were treated at the 400 microg/d dose. In addition, at the 400 microg/d dose, one patient achieved a very good partial response, and one achieved a partial response. The overall response rate at 400 microg/d was 70%. The median duration of response was nine months. Median time to response was one month, with 11 of 13 patients responding in the first cycle. Serious adverse events were reported in 19 patients. Sixteen required hospitalization and four had prolonged hospitalization. No grade 3 or 4 central nervous system toxicities were observed. Serious AEs occurring in more than one patient included infections and peripheral polyneuropathy. Treatment-related serious AEs included polyneuropathy and edema. Grade 3 cytokine release syndrome was seen in one patient. Two patients died during the study from AEs not considered treatment-related: one patient died from acute respiratory distress due to concurrent flu and aspergillosis, and the second patient died from liver failure secondary to a viral infection during the course of treatment. Initial results from a Phase 1 dose-escalation study of investigational AMG 212, in patients with mCRPC who are refractory to standard therapy were presented in a poster at the ASCO Annual Meeting. In the trial, 16 patients with mCRPC were enrolled into five dosing cohorts, with a target dose range of 5 to 80 microg/d delivered by continuous intravenous infusion. The primary objective was to determine safety and MTD and secondary objectives included pharmacokinetics, biomarkers and tumor response. Antitumor activity as indicated by decline in serum level of prostate-specific antigen was dose dependent. PSA decreases of greater than or equal to 50 percent occurred in three patients. One long-term responder was treated for 14 months and one for 19.4 months. The latter patient showed a complete regression of soft-tissue metastases and marked regression of bone metastases, as well as a significant and durable improvement in disease-related symptoms. Recruitment in the trial was stopped before MTD was reached to facilitate initiation of a new study sponsored by Amgen.

15:00 EDT Ziopharm provides data from two ongoing substudies in Controlled IL-12 platform - Ziopharm Oncology announced the presentation of new interim analyses of clinical data from two ongoing substudies in its Controlled IL-12 platform, or Ad-RTS-hIL-12 plus veledimex, both as monotherapy and in combination with a PD-1 inhibitor, for the treatment of recurrent or progressive glioblastoma multiforme in adults, at the American Society for Clinical Oncology Annual Meeting. In the setting of rGBM, the Company previously reported phase 1 data from the "Main Study" which demonstrated an increased median overall survival of 12.7 months with 13.1 months follow up for 15 patients that received 20mg/day veledimex, which further improved to 17.8 months in the 40% of patients receiving low-dose steroids.1 In this study, improvements in mOS correlated with IL-12-mediated activation of peripheral blood immune cells as assessed by serially measuring the ratio of CD8+/FoxP3+ T cells described as "cytoindex." These data support Ziopharm's continued development of its Ad-RTS-hIL-12 plus veledimex as a drug to control the production of interleukin 12.

14:54 EDT Myriad Genetics presents results on BRACAnalysis CDx Companion diagnostic test - Myriad Genetics (MYGN) announced that its BRACAnalysis CDx companion diagnostic test effectively identified patients with metastatic pancreatic cancer who benefitted from treatment with Lynparza in the Phase III POLO study. Specifically, the POLO study demonstrated that patients with a germline mutation, and whose disease had not progressed on first-line platinum-based chemotherapy, had a clinically-meaningful and statistically-significant improvement in progression-free survival of 7.4 months when treated with Lynparza compared to 3.8 months for placebo. Lynparza is a novel PARP inhibitor being commercialized by AstraZeneca (AZN) and Merck (MRK) and is not currently approved by the U.S. Food and Drug Administration for gBRCAm pancreatic cancer. In February, the National Comprehensive Cancer Network updated its guidelines to recommend universal germline BRCA testing for all patients with pancreatic cancer. Pancreatic cancer is the third most common cause of cancer-related death in the United States, and it is estimated that germline BRCA-mutated pancreatic cancer accounts for approximately seven percent of all cases. Myriad previously announced that it intends to file a supplementary Premarket Approval application with the FDA to authorize BRACAnalysis CDx as a companion diagnostic for Lynparza in patients with pancreatic cancer. The company also has signed an exclusive commercialization agreement with AstraZeneca.

14:48 EDT Puma Biotechnology presents interim results of Phase II CONTROL trial - Puma Biotechnology presented updated interim results from a Phase II clinical trial of Puma's drug neratinib at the American Society of Clinical Oncology 2019 Annual Meeting in Chicago. Neratinib was approved by the U.S. Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the U.S. as NERLYNX tablets. The main adverse event seen to date in clinical trials of neratinib is diarrhea and, more specifically, grade 3 diarrhea. In the Phase III ExteNET trial of neratinib as extended adjuvant treatment of HER2-positive early stage breast cancer that has previously been treated with adjuvant Herceptin, prophylactic use of anti-diarrheal medications was not mandatory. In the trial, 95.4% of the patients experienced all grade diarrhea and 39.8% of the patients experienced grade 3 or higher diarrhea. The median cumulative duration of grade 3 diarrhea in the ExteNET trial was 5 days and 16.8% of patients who received neratinib in the ExteNET trial discontinued the drug due to diarrhea. The CONTROL trial is an international, open-label, Phase II study investigating the use of antidiarrheal prophylaxis or dose escalation in the reduction of neratinib-associated diarrhea that has a primary endpoint of the incidence of grade 3 diarrhea. In the CONTROL trial, patients with HER2-positive early stage breast cancer who had completed trastuzumab-based adjuvant therapy received neratinib daily for a period of one year. The trial initially tested high dose loperamide prophylaxis given for the first 2 cycles of treatment. The CONTROL trial was then expanded to include four additional cohorts. One cohort received the combination of loperamide and budesonide, the second cohort received the combination of loperamide plus colestipol, the third cohort received colestipol plus loperamide as needed and the fourth cohort did not use any antidiarrheal drugs as mandatory prophylaxis but instead used a dose escalation during the first month of neratinib treatment. The dose escalation involved treating with neratinib at 120 mg per day for the first week, 160 mg per week for the second week and 240 mg per week starting at week 3 and until the end of treatment. The interim analysis of the CONTROL trial presented in the poster included a total of 137 patients who received neratinib plus loperamide prophylaxis, 64 patients who received neratinib plus loperamide prophylaxis for 2 cycles and budesonide for 1 cycle, 136 patients who received neratinib plus loperamide prophylaxis for 1 cycle and colestipol for 1 cycle, 104 patients who received colestipol for 1 cycle and loperamide as needed and 60 patients who received the dose escalation regimen of neratinib.

14:41 EDT Aimmune presents topline results from pivotal European Phase 3 ARTEMIS trial - Aimmune Therapeutics presented topline results from the pivotal European Phase 3 ARTEMIS clinical trial, which it previously announced had met its primary endpoint, demonstrating the efficacy and safety of AR101 in peanut-allergic children and adolescents after six months of dose escalation and a three-month therapeutic dosing phase. The findings from the ARTEMIS trial reinforce the consistent clinical profile of AR101, demonstrating that patients tolerated 1,000 mg of peanut protein after only nine months of treatment, which was the primary endpoint of the study. The ARTEMIS study builds on the results of the landmark PALISADE trial, which met its primary endpoint of patients tolerating 600 mg of peanut protein at 12 months. AR101 is an investigational biologic drug for use in oral immunotherapy as a treatment to reduce the frequency and severity of allergic reactions following exposure to peanuts. The proportion of AR101-treated patients who tolerated the 1,000 mg dose of peanut protein in the double-blind, placebo-controlled food challenge was significantly higher than in the placebo group: 58% vs. 2%. The AR101-treated patients had less severe symptoms during the exit peanut DBPCFC, compared with the placebo-treated patients. In the study, 175 subjects aged 4 to 17 years in seven European countries were randomized 3:1 to AR101 or placebo, up-dosed to 6 mg on day 1 and received dose escalations every two weeks for 20-40 weeks until the therapeutic dose of 300 mg was reached. This was followed by approximately three months of continued 300 mg/day therapeutic dosing. The primary endpoint was the ability to tolerate at least 1,000 mg of peanut protein as a single dose without dose-limiting symptoms at exit DBPCFC. The safety profile of AR101 was consistent with previous AR101 studies with the frequency and severity of allergic reactions as expected for an oral desensitization therapy. Mild or moderate systemic allergic reactions were reported in 12.1% of AR101-treated subjects and 2.3% of placebo-treated subjects. Epinephrine/adrenaline use was reported in 6.8% of AR101 treated participants versus 2.3% of placebo, all for mild/moderate reactions and lower than reported in PALISADE. Discontinuations due to related adverse events affected 9.8% of AR101-treated subjects, with no serious adverse events reported that led to discontinuation, and no deaths or suspected unexpected serious adverse reactions. There were no reported cases of eosinophilic esophagitis and no cases of severe anaphylaxis.

14:35 EDT G1 Therapeutics presents additional Phase 2 data on Trilaciclib in SCLC - G1 Therapeutics presented additional findings from a randomized Phase 2 clinical trial demonstrating the myelopreservation benefits of trilaciclib in patients undergoing chemotherapy treatment for 2nd/3rd-line small cell lung cancer. Trilaciclib is a first-in-class myelopreservation agent designed to protect the bone marrow from damage by chemotherapy and improve patient outcomes. In December 2018, the company announced topline data showing that SCLC patients receiving trilaciclib + topotecan experienced statistically significant reductions in the duration and occurrence of Grade 4 neutropenia, and that trilaciclib treatment resulted in a reduction in the number of granulocyte colony-stimulating factor administrations and red blood cell transfusions, compared to patients receiving placebo + topotecan. Overall, patients receiving trilaciclib + topotecan showed an improved safety profile compared to those receiving placebo + topotecan. An analysis of patient-reported outcomes data showed clinically meaningful improvements in the treatment experience for patients receiving trilaciclib + topotecan compared to those receiving placebo + topotecan. Patients receiving trilaciclib reported significant improvements in several areas, including: general and physical wellbeing, quality-of-life measures specific to lung cancer patients, symptoms and impact of fatigue, and symptoms and effects on physical and functional wellbeing due to anemia.

14:28 EDT Dynavax presents Phase 2 data on SD-101 in combination with Keytruda - Dynavax Technologies (DVAX) announced favorable results from the Phase 2 cohort expansion of the Phase 1b/2, open-label, multicenter study of intratumoral SD-101 in combination with Merck's (MRK) Keytruda in anti-PD-1 treatment-naive patients with recurrent or metastatic head and neck squamous cell carcinoma. In the Phase 1b/2 clinical study in patients with recurrent or metastatic HNSCC, SD-101 is administered intratumorally with 8 mg in 1 lesion or 2 mg in 1-4 lesions combined with intravenous administration of 200 mg of pembrolizumab. An ORR of 22.2% in the 2 mg cohort and an ORR of 26.1% in the 8 mg cohort were observed. An ORR of 33.3% and a disease control rate of 41.6% were observed in patients with low PD-L1 status at baseline. An ORR of 36% was observed in patients with HPV-positive tumors. Biomarker data are consistent with the mechanism of action of SD-101 and demonstrate strong immunomodulation of the tumor microenvironment including infiltration of activated T cells and upregulation of Type I and Type II Interferon. Importantly, similar to what was reported for melanoma patients who had not received anti-PD-1 therapy, patients whose tumors exhibited an immunologically cold tumor microenvironment at baseline showed clinical response during SD-101 plus pembrolizumab treatment. The combination of SD-101 and pembrolizumab was well-tolerated, consistent with previous reports. No evidence of an increased incidence or severity of adverse events over pembrolizumab monotherapy. No increase in immune-related AEs over pembrolizumab monotherapy. AEs associated with SD-101 were mainly mild to moderate injection-site reactions and flu-like symptoms that were manageable with over-the-counter medication.

14:22 EDT Veracyte announces new data for Afirma Xpression Atlas genomic test - Veracyte announced new data demonstrating the potential for its Afirma Xpression Atlas genomic test to guide targeted treatment selection for patients with a rare but aggressive form of thyroid cancer concurrent with diagnosis by the company's Afirma Genomic Sequencing Classifier. Researchers used the Afirma XA to conduct RNA sequencing on 90 thyroid fine needle aspiration samples that had been diagnosed with medullary thyroid cancer through the Afirma GSC. The cohort was derived from nearly 30,000 sequential samples that were indeterminate or suspicious for cancer following traditional cytopathology testing. The researchers found that the Afirma XA identified a gene variant or fusion in 74% of the MTC cases and that 99 percent of these cases had one or more variants or fusions - RET, KRAS, HRAS and/or BRAF alterations - that are targeted by new therapies that are currently in clinical trials or early stage development. The test helps identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to help patients avoid unnecessary diagnostic thyroid surgery, while also identifying patients with MTC. The Afirma XA provides physicians with genomic alteration content from the same fine needle aspiration samples that are used in Afirma GSC testing and may help physicians decide with greater confidence on the surgical or therapeutic pathway for their patients. The Afirma XA includes 761 DNA variants and 130 RNA fusion partners in over 500 genes that are associated with thyroid cancer.

14:16 EDT Sierra Oncology announces preliminary efficacy in SRA737 clinical program - Sierra Oncology reported preliminary clinical data from its two first-in-human Phase 1/2 studies of SRA737, a highly selective oral Chk1 inhibitor, as monotherapy and as SRA737+LDG, at the 2019 Annual Meeting of the American Society of Clinical Oncology. Anti-cancer activity was demonstrated across multiple indications and genetic contexts, with SRA737+LDG specifically achieving a 30% response rate in anogenital cancer patients. This signal-seeking Phase 1/2 study was designed to investigate the safety and tolerability of SRA737 in combination with sub-therapeutic, low dose gemcitabine, as well as to evaluate preliminary anti-tumor activity of SRA737 potentiated by LDG in tumors with genetic alterations predicted to confer increased intrinsic RS and Chk1i sensitivity. Relative to standard-of-care, gemcitabine doses tested were approximately 10-25% of a standard chemotherapeutic dose. Anti-tumor activity was observed in subjects with advanced anogenital cancer, encompassing "noteworthy tumor decreases and promising durations of treatment," according to the company. Overall, Partial Responses were observed in six subjects and 41 subjects had a best response of Stable Disease; durable SD lasting greater than or equal to 4 months was recorded in 32 subjects and was observed in all expansion cohorts. The combination of SRA737+LDG was generally well tolerated. There was no evidence of emergent or cumulative toxicity and/or declining tolerability with up to 13 cycles of treatment. At the time of the data cut off, 22 subjects remained on study treatment. Based on overall tolerability, the recommended Phase 2 dose is 500 mg SRA737 + 250 mg/m2 LDG.

14:02 EDT Blueprint Medicines presents NAVIGATOR trial data of avapritinib - Blueprint Medicines announced data from the registration-enabling NAVIGATOR trial of avapritinib in patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumors and fourth-line GIST. These results were presented at the American Society of Clinical Oncology 2019 Annual Meeting and will form the basis for planned worldwide marketing applications for avapritinib, an investigational, highly selective KIT and PDGFRA inhibitor for patients with advanced GIST. The data demonstrate clinical activity and favorable tolerability in patients with PDGFRA Exon 18 mutant and fourth-line GIST, two populations with no effective therapies. Data from the ongoing NAVIGATOR trial in patients with PDGFRA Exon 18 mutant GIST, which primarily includes the D842V mutation, and fourth-line GIST support Blueprint Medicines' plans to submit a New Drug Application to the U.S. Food and Drug Administration in June 2019 and a Marketing Authorization Application to the European Medicines Agency in the third quarter of 2019. Avapritinib has received FDA Breakthrough Therapy Designation for the treatment of patients with unresectable or metastatic GIST harboring the PDGFRalpha D842V mutation. In patients with PDGFRA Exon 18 mutant GIST, the objective response rate was 86% and the median duration of response was not reached. In patients with fourth-line GIST, the ORR was 22% and the median DOR was 10.2 months. ORR and DOR per central radiographic review will be the primary registrational endpoints. Avapritinib was well-tolerated with most adverse events reported by investigators as Grade 1 or 2. These results were as of a data cutoff date of November 16, 2018.

13:57 EDT Atara Biotherapeutics presents Tab-cel clinical biomarker results - Atara Biotherapeutics presented results showing that circulating EBV-targeted cytotoxic T lymphocyte precursors could serve as a biomarker of clinical response to tab-cel in patients with EBV-driven diseases. Ten tab-cel-treated patients with EBV-associated diseases from a multicenter expanded access protocol study were selected. In this cohort, ex-vivo analyses of circulating EBV-CTLp following administration of tab-cel showed a statistically significant correlation with clinical response. A second presentation described the design of an ongoing Phase 1b/2 clinical study of tab-cel in combination with pembrolizumab for patients with platinum-resistant or recurrent EBV-associated nasopharyngeal carcinoma. Tab-cel has been evaluated as a single agent in previous studies where evidence of radiographic response was observed in patients with chemotherapy refractory, metastatic NPC.

13:52 EDT Replimune announces initiation of Phase 2 of RP1 trial - Replimune announced that the Phase 2 portion of the Company's Phase 1/2 clinical trial of RP1 alone and in combination with nivolumab anti-PD1 therapy has initiated. In the Phase 2 portion of the clinical trial, RP1 in combination with nivolumab will be tested in four 30-patient cohorts of patients with melanoma, non-melanoma skin cancers, metastatic bladder cancer or microsatellite instability-high tumors. Enrollment is now open in the melanoma, NMSC and bladder cancer cohorts, and enrollment in the MSI-H cohort will open as soon as a protocol-required MSI-H patient is evaluable from Phase 1. The patients enrolled into the melanoma cohort either will be treatment naive or have received one prior systemic therapy, and the patients enrolled into the other three cohorts will all be naive to anti-PD1 therapy. Data relating to the Phase 1 portion of the clinical trial, including biomarker data, is expected to be presented at a medical conference in the fourth quarter of 2019. The Phase 1 portion tested single agent RP1 by direct injection into a single superficial or nodal tumor and by imaging guided injection into a single visceral tumor in patients with advanced heavily pre-treated cancers who failed available therapy to define the recommended Phase 2 dose. Following determination of the recommended Phase 2 dose, an expansion group of advanced cancer patients who failed available therapy then received RP1 at the recommended Phase 2 dose in combination with nivolumab at standard clinical doses. The company also announced that a trial in progress poster was presented at the 2019 American Society of Clinical Oncology Annual Meeting.

13:46 EDT BeiGene announces preliminary Phase 2 results of Tislelizumab in NPC - BeiGene announced preliminary results of tislelizumab, its investigational anti-PD-1 inhibitor, in Chinese patients with nasopharyngeal cancer that were presented in a poster at the 2019 American Society of Clinical Oncology Annual Meeting. The multi-center, open-label Phase 1/2 trial of tislelizumab as monotherapy in advanced solid tumors in China consists of a Phase 1 dose verification and pharmacokinetics component and a Phase 2 component of indication expansion in disease-specific cohorts, including patients with NPC solid tumors. Data presented at ASCO today are from 21 patients with NPC, of whom 20 were enrolled in the Phase 2 indication-expansion portion of the trial. Patients were treated with tislelizumab at a dose of 200 mg every three weeks. 95% of the study population received one or more prior regimens of systemic therapy. At the time of the data cutoff on December 1, 2018, median treatment duration was 7.5 months, median follow-up time was 11.7 months, and nine patients remained on treatment. Adverse events assessed by the investigator to be related to treatment occurred in 14 patients. Of those, the most common treatment-related AEs were hypothyroidism, anemia, increased AST, and hemoptysis. There was one grade 4 cutaneous reaction TRAE that led to discontinuation. Of the eight patients who experienced immune-related AEs, two patients experienced three grade greater than or equal to3 irAEs. No patients experienced fatal TRAEs. As of the data cutoff, all 21 patients were evaluable for antitumor activity. A total of nine patients achieved a confirmed partial response and nine patients achieved stable disease. Clinical benefit was observed regardless of PD-L1 expression. The confirmed objective response rate was 43% . Median duration of response was estimated as 8.3 months and median progression-free survival was 10.4 months; however, data were not yet mature enough to estimate overall survival.

13:40 EDT Moderna presents data from Phase 1 study in resected, unresected solid tumors - Moderna (MRNA) announced interim data from an ongoing Phase 1 clinical study in patients with both resected and unresected solid tumors. The data showed that the company's mRNA personalized cancer vaccine mRNA-4157, given alone or in combination with Merck's (MRK) pembrolizumab, was well-tolerated at all doses tested and elicited neoantigen-specific T-cell responses. There were no vaccine-related serious adverse events reported for the PCV when administered to patients as a monotherapy or in combination with pembrolizumab. The study demonstrates the immunogenicity of Moderna's mRNA platform for developing PCVs. In addition, clinical activity was observed in some patients receiving mRNA-4157 in combination with pembrolizumab. These safety, tolerability and immunogenicity data and the initial clinical activity observed support Moderna's randomized Phase 2 study investigating pembrolizumab in combination with a 1 mg dose of mRNA-4157, compared to pembrolizumab alone, for the treatment of high-risk adjuvant melanoma.

13:27 EDT Clovis announces expanded Rubraca data from ARIEL3, TRITON2 trials - Clovis Oncology announced multiple datasets presented at the 2019 American Society of Clinical Oncology Annual Meeting in Chicago, including presentations of exploratory endpoint evaluations and updated safety data from the pivotal Phase 3 ARIEL3 trial evaluating Rubraca for the maintenance treatment of advanced ovarian cancer, as well as genomic characteristics of BRCA1/2 mutations among metastatic castration-resistant prostate cancer patients in the Phase 2 TRITON2 trial evaluating Rubraca in mCRPC. Data from this analysis of the ARIEL3 trial, which enrolled patients with platinum-sensitive recurrent ovarian carcinoma, demonstrated that Rubraca significantly improved the clinically meaningful exploratory endpoints of chemotherapy-free interval, time to start of first subsequent therapy, time to investigator-assessed progression on the subsequent line of treatment or death, and time to second subsequent therapy vs. placebo. The updated safety profile generated in this analysis is consistent with the previously-reported primary efficacy data analysis based on a data cutoff date of April 15, 2017. As of December 31, 2017, the most common treatment-emergent adverse events of any grade were nausea, asthenia/fatigue, dysgeusia, and anemia/decreased hemoglobin. The most common grade greater than or equal to TEAEs were anemia/decreased hemoglobin and alanine/aspartate aminotransferase increase. The ongoing phase 2 TRITON2 study is evaluating the poly(ADP-ribose) polymerase inhibitor rucaparib in mCRPC patients harboring a deleterious germline or somatic mutation in BRCA1, BRCA2, ATM, or other DNA damage repair genes as determined by central screening of tumor tissue or plasma, or from local testing. Next-generation sequencing assays evaluating tumor tissue and circulating cell-free tumor DNA in plasma were both used to successfully identify patients with eligible alterations in BRCA1/2. The plasma assay is minimally invasive and reliably detects alterations in patients with disease that is difficult to biopsy. In this analysis, associations between baseline genomic and clinical characteristics were assessed. Several findings support the hypothesis that germline BRCA1/2 alterations are a prognostic factor in prostate cancer associated with more rapid progression to advanced disease. Patients with germline BRCA1/2 alterations were younger at time of enrollment into TRITON2, had more advanced disease at time of diagnosis and had a shorter time between diagnosis and enrollment into TRITON2 as compared to patients with somatic BRCA1/2 alterations. However, responses to rucaparib were observed in patients with germline or somatic BRCA1/2 alterations, highlighting the potential of rucaparib to benefit both groups of patients. The poster includes the confirmed objective response rate data based on the same June 29, 2018 visit cut-off date presented at ESMO 2018 and presents those data by germline or somatic BRCA1/2 mutation status. By investigator-assessed RECIST/PCWG3, the confirmed ORR in patients with a germline or somatic BRCA1/2 mutation treated with Rubraca was 50% or 40%, respectively. By PSA response, the confirmed ORR in patients with a germline or somatic BRCA1/2 mutation treated with Rubraca was 66.7% or 43.3%, respectively.

13:09 EDT Silicon Motion completes sale of FCI to Dialog Semiconductor - Silicon Motion Technology (SIMO) announced that it has completed the sale of FCI, its Mobile Communications product line, to Dialog Semiconductor (DLGNF).

13:04 EDT Clovis says Rubraca 'significantly improved' exploratory endpoints - Clovis Oncology announced multiple datasets being presented at the 2019 American Society of Clinical Oncology Annual Meeting in Chicago. These include presentations of exploratory endpoint evaluations and updated safety data from the pivotal Phase 3 ARIEL3 trial evaluating Rubraca for the maintenance treatment of advanced ovarian cancer, as well as genomic characteristics of BRCA1/2 mutations among metastatic castration-resistant prostate cancer patients in the Phase 2 TRITON2 trial evaluating Rubraca in mCRPC, the company said. "The breadth and depth of data from both company and investigator-sponsored Rubraca trials presented at this year's ASCO meeting demonstrate the growing strength of the data and clinical development programs behind Rubraca," said Patrick Mahaffy, President and CEO of Clovis Oncology. "Accordingly, we look forward to presenting updated clinical data from the TRITON2 study at an upcoming medical conference in the second half of 2019 and submitting our planned supplemental NDA filing for BRCA-mutant advanced prostate cancer in Q4 2019." Data from this analysis of the ARIEL3 trial, which enrolled patients with platinum-sensitive recurrent ovarian carcinoma, demonstrated that Rubraca "significantly improved" the clinically meaningful exploratory endpoints of chemotherapy-free interval, time to start of first subsequent therapy, time to investigator-assessed progression on the subsequent line of treatment or death, and time to second subsequent therapy verus placebo, according to Clovis. The updated safety profile generated in the analysis is consistent with the previously-reported primary efficacy data analysis based on a data cutoff date of April 15, 2017, it added.